1. Sopio Gokadze PhD student
3rd World Congress on Pharmacology
Development of Wound Healing Ointment on the Basis of Natural Biopolymers
Sopio Gokadze PhD student

2. INTRODUCTION
Comfrey (Symphytum) is a plant that has been used as a herbal medicine for >2000 years for the treatment of broken bones, tendon damage, ulcerations in the gastrointestinal tract, and lung congestion. In folk medicine galenic preparations from comfrey are used for the acceleration of regeneration processes.
In recent years the investigations of high-molecular fraction of polysacharides from roots and aereal parts of comfrey was made and it vas found out that phenolic polymer poly[oxy-1-carboxy-2-(3,4- dihydroxyphenyl)ethylene] (PODPE) as a dominant structural element, which is responsible for pharmacological properties of comfrey preparations.
Main goal of research is to developed an ointment on the basis of PODPE.

3. Caucasian Species of Comfrey (Symphytum L.)
Symphytum asperum
Symphytum caucasicum

4. Objectives Development of an ointment on the basis of PODPE
Determination of the optimal base content
Determination of ointment stability
Biopharmaceutical studies. Release of the active substance from the finished forms
Preclinical testing. Investigation of specific activity and safety of active substance and finished form in in vivo experiments

5. Obtaining of PODPE from the raw material

6. Technological scheme Solubilization of base reactor
Mixing of active ingredient and base
Homogenisation of ointment
packaging
Standardization
reactor
homogenizer

7. Detremination of optimal content of the base
Content g/№ 1 2 3 4 5 6 7 8
PDGA
10,0
Petroleum jelly
90,0
64,0
75,0
Anhydrous Lanolin
18,0
Water
73,0
80,0
88,0
81,0
20,0
Sodium carboxymethyk cellylose
8,0
7,0
Polyethylene Glycol 1000 (PEG1000)
60,0
Glycerin
30,0
Sodium Alginate
2,0
Clay Askane
9,0
Polysorbate -80
5,0

8. Stability after centrifugation
Base N
Consistence
Stability after centrifugation
After preparing
After 24 hr delaying
+20 ºC
0ºC
+45ºC 1
Dense , Homogeneous 2
Soft, Homogeneous 3
liquid 4
Slight separation 5 6 7
Separation 8
K conditions: centrifugation rpm during 5 minute, after 24 hr saving on the temperature 0ºC, +20 ºC, +45ºC. Stability was only failure in emuslive ointment

9. Description or specification
Quality parameters
parameter
Description or specification 1 2
Description
Homogenous , brown mass
Smell
Specific like plant PH
6,5 – 7,2
Thermal stability
-7°C დან +37°C
Colloidal stability
stabilized
Identity
Straw-coloured FeCl3 ;
UV absorbtion at λ=
286 nm
Quantitative content of PDGM %
1,5
Microbial contamination
Sterile

10. Biopharmaceutical Studies
Base s
Coloured zone diameter (mm)
Diffusion ceofficient
1 hr 3 7 24 48 72
Temperature 20ºC 1 8 9 15 17
5,6 2 11 19 26 37
21,4 12 39 43 45
35,4 4 16 27
37,6 5 18 23 34 52 59
49,2 6 36 55 62
52,5
5,3 10 35
19.6
Temperature 32ºC 22
34,4 40 47 51
40,2 13 38 50 54
44,0 56
47,2 46 65
59,2 32 63 69
62,4 20 25 28
35,7 14 42
37.7
Best result of release N6 composition: PDGA Water Sodium Alginate

11. PPPharmacological assayB
Dynamics of wound healing
Wound area (mm2)
days
control
ointment
ointment base
Wound healing effect of 5% PODPE ointment

12. Conclusions
The optimal ointment formulation has been justified on the basis of experimental studies carried out;
The ointment remains stable both right after manufacturing and during storage at different temperatures for 24 hours with following centrifugation..
Biopharmaceutical studies established that the maximal release of PDGA from the ointment was achieved when sodium alginatis was used for an ointment base.
Animal studies revealed that the ointment exhibits pronounced wound healing action.

13. Thank you !